Regulatory Analyst 1
Regulatory Analyst 1
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Job Description
Current Employees:
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The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Remote Regulatory Analyst 1.
CORE JOB SUMMARY:
The SCCC department is seeking a Regulatory Analyst 1 that will be responsible for conducting the onsite audits reviewing consolidated records (the results of the records once the new data are added) designing reviewing and testing the revised treatment matrix which will identify possible cancers from claims data. The RA1 will facilitate the process of preparing required regulatory documentation for initial and subsequent study submissions to various boards committees industry academic and cooperative sponsors. Provides regulatory support for multiple clinical trials from study startup through study closure. Generates and updates essential regulatory documents accordingly including the editing of consent forms appropriately based on required institutional language and/or study revisions. Attends site visits conducted by sponsor/Contract Research Organization (CRO) for matters concerning regulatory documents. Maintains current knowledge of applicable regulatory topics (e.g. institutional SOPs federal regulations etc. and adheres to university and departmentlevel policies and procedures and safeguards University assets. Ensures compliance of general and study specific regulatory related processes with SOPs FDA NIH and other applicable regulations.
CORE JOB FUNCTIONS:
Analyzes regulatory requirements identifying potential conflicts and has thorough knowledge and ability to apply federal regulations and University policies.
Oversees accurate and timely processing tracking and filing of submissions to and actions which includes monthly notifications on submissions for federally mandated deadlines.
Assists with drafting preparation and presentation of programs to investigators and their research staff to raise and maintain knowledge and awareness of research compliance.
Provides support to investigators by reviewing submissions for content.
Sends decision correspondence to appropriate parties requesting information.
Maintains accurate databases generate letters develops and maintains templates creates files and mailing notices.
Develops and maintains templates creates files and mails notices. Adheres to University and unitlevel policies and procedures and safeguards University assets.
This list of duties and responsibilities is not intended to be allinclusive and may be expanded to include other duties or responsibilities as necessary.
CORE QUALIFICATIONS:
Education: Bachelors degree in relevant field
Experience: Minimum 1 year of relevant experience
Any relevant education certifications and/or work experience may be considered
Department Specific Functions
DUTIES & RESPONSIBILITIES:
Job duties will include but not be limited to:
Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study startup to study closure including communicating with ancillary committees study team business office contract research organizations and sponsors.
Completion of the new protocol submission packet with the information provided by PRMC as well as any additional required documentation (i.e. local protocol HIPAA forms etc.. Modifying and standardizing consent forms for IRB submission is required.
Compilation of documents in order to prepare the following forms for IRB submission to ensure protocol compliance with federal regulations.
This process will take place from study startup throughout the completion of the study.
Initial IRB application
Amendments / modifications
Reportable new information
Protocol deviations / violations
Protocol exceptions
IND safety letters
Continuing and final reports
Other communications from the sponsor requiring IRB submission.
- Preparation and maintenance of regulatory binders (paper or electronic) with all necessary study documentation in compliance with institutional standard operating procedures (SOPs) sponsor requirements (as applicable) and applicable regulatory requirements.
- Communication with study staff to ensure the maintenance and accuracy of the Delegation of Authority Log (DOAL). Ensure in conjunction with the DOAL that all protocolrelated training (whether initial or with a new study protocol amendment/modification) is completed for all study personnel and documentation maintained within the regulatory binder.
- Maintains department credentialing information and research records for clinical trials within institutions electronic systems (e.g. Velos Complion) and appropriate drives as applicable.
- Participate in site visits with monitors as well as site audits concerning compliance of regulatory documents. Ensure timely resolution of observations identified during monitoring and auditing visits.
- Communicate with Clinical Coordinators and PIs to review and submit protocol deviations and amendments as part of the plan to resolve the deficiencies identified during the audit/monitoring visit.
- Assist in the collection and maintenance of credentialing information for study personnel (e.g. studyspecific training IBC EHS requirements etc..
- Upkeep of departmental trackers with study updates to ensure study team personnel are effectively alerted of initial study approvals and IRB approved study and consent amendments.
- Communicate to SCCC staff and PI relevant aspects of the regulatory process concerning IRB approval of initial protocol exceptions continuing reports and study modifications. This includes facilitation of training and notification of required reconsenting in collaboration with the clinical team following approval of study modifications.
- Provides updates to the study team and/or management regarding submission statuses and approvals (e.g. initial and amendments) during internal team meetings and upon request.
- Communicate with the sponsor and/or contract research organization for completion and submission of regulatory documents via interlinks regular mail or email as well as provide submission updates upon request. This responsibility is sponsor dependent. The following documents may be included:
Financial Disclosure Forms
FDA 1572
Initial Protocol Signature Page
Amendments signature page
Investigators CV and Medical Licenses
Laboratories normal ranges and certifications
IRB approvals
Approved consents
Other documents as required by the sponsor
Provide feedback to Regulatory Management on opportunities for regulatory process improvement.
Identifies and escalates issues before they become critical.
Assists with various regulatory related projects under the direction of the Regulatory Manager and/or Director of Regulatory.
Other duties as assigned by senior management.
Education:
Bachelors degree
In lieu of bachelors degree years of relevant experience in clinical research compliance research or a medical setting may be substituted for the educational requirement.
Certification and Licensing:
Not required
Experience:
Minimum one 1 year of relevant experience in compliance research or a medical setting.
Experience in clinical trials is preferred.
Knowledge Skills and Attitudes:
Skill in completing assignments accurately and with attention to detail.
Ability to communicate effectively in both oral and written form.
Ability to handle difficult and stressful situations with professional composure.
Ability to maintain effective interpersonal relationships.
Ability to understand and follow instructions.
#LIYC1
The University of Miami offers competitive salaries and a comprehensive benefits package including medical dental tuition remission and more.
UHealthUniversity of Miami Health System South Floridas only universitybased health system provides leadingedge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center we are proud to serve South Florida Latin America and the Caribbean. Our physicians represent more than 100 specialties and subspecialties and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching research and patient care. Were the challenge youve been looking for.
The University of Miami is an Equal Opportunity Employer Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.
Job Status:
Full timeEmployee Type:
StaffPay Grade:
H7Required Experience:
IC
Employment Type
Full-Time
